No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 15099590704087 | B1017-435 | Neg Urine Combo 85 | LQM,LTW,LRG,JWY,LTT | Gram Negative Identification Panel,Susceptibility Test Cards, Antimicrobial,Inst Gram Negative Identification Panel,Susceptibility Test Cards, Antimicrobial,Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems,Manual Antimicrobial Susceptibility Test Systems,Panels, Test, Susceptibility, Antimicrobial | MicroScan | ||
2 | 15099590704070 | B1017-434 | Neg Urine Combo 84 | LQM,LTW,LRG,JWY,LTT | Gram Negative Identification Panel,Susceptibility Test Cards, Antimicrobial,Inst Gram Negative Identification Panel,Susceptibility Test Cards, Antimicrobial,Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems,Manual Antimicrobial Susceptibility Test Systems,Panels, Test, Susceptibility, Antimicrobial | MicroScan | ||
3 | 15099590765385 | C89645 | Neg Urine Combo 103 | JWY,LRG,LTT,LTW,LQM | Manual Antimicrobial Susceptibility Test Systems,Instrument For Auto Reader & In Manual Antimicrobial Susceptibility Test Systems,Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems,Panels, Test, Susceptibility, Antimicrobial,Susceptibility Test Cards, Antimicrobial,Gram Negative Identification Panel | 1 | MicroScan | |
4 | 15099590733919 | C48640 | Neg Urine Combo 90 | LQM,LTW,LTT,LRG,JWY | Gram Negative Identification Panel,Susceptibility Test Cards, Antimicrobial,Pane Gram Negative Identification Panel,Susceptibility Test Cards, Antimicrobial,Panels, Test, Susceptibility, Antimicrobial,Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems,Manual Antimicrobial Susceptibility Test Systems | MicroScan | ||
5 | 15099590707118 | DxA 5000 | DxA 5000 | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | DxA 5000 | |
6 | 15099590540210 | 6607098 | 6607098 | IMMUNO-TROL Low Cells | JPK | Mixture, Hematology Quality Control | 2 | IMMUNO-TROL Low Cells |
7 | 15099590250683 | 7546914 | 7546914 | COULTER LATRON Control | GKL | Counter, Cell, Automated (Particle Counter) | 2 | COULTER Latron |
8 | 15099590060206 | OSR6637 | Bicarbonate | KHS | Enzymatic, Carbon-Dioxide | 2 | AU | |
9 | 15099590222925 | 465980 | 465980 | Vigil Lipid Control Level 2 | JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 | Vigil |
10 | 15099590742751 | C69058 | C69058 | The Access SARS-CoV-2 IgG II Calibrators are intended to calibrate the Access SA The Access SARS-CoV-2 IgG II Calibrators are intended to calibrate the Access SARS-CoV-2 IgG II assay for the in vitro semi-quantitative and qualitative detection of SARS-CoV-2 IgG antibodies in human plasma (lithium heparin, dipotassium EDTA, tripotassium EDTA, and sodium citrate) for use on the Access Immunoassay Systems only.The Access SARS-CoV-2 IgG II calibrators are only for use under the Food and Drug Administration's Emergency Use Authorization. | QKO | Reagent, Coronavirus Serological | Access SARS-CoV-2 IgG II Calibrator | |
11 | 15099590701574 | C11478 | UniCel DxH 900 Coulter Cellular Analysis System | GKZ | Counter, Differential Cell | 2 | DxH 900 Hematology System | |
12 | 15099590672539 | B36633 | B36633 | CYTO-STAT /COULTER CLONE MsIgG2a-RD1 (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | CYTO-STAT /COULTER CLONE MsIgG2a-RD1 |
13 | 15099590672522 | B36631 | B36631 | CYTO-STAT /COULTER CLONE Mo2-FITC (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | CYTO-STAT /COULTER CLONE Mo2-FITC |
14 | 15099590672461 | B36623 | B36623 | CYTO-STAT /COULTER CLONE MsIgG2b-FITC (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | CYTO-STAT /COULTER CLONE MsIgG2b-FITC |
15 | 15099590672454 | B36536 | B36536 | CYTO-STAT /COULTER CLONE B4-RD1 (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | CYTO-STAT /COULTER CLONE B4-RD1 |
16 | 15099590663827 | 8448044 | 8448044 | COULTER Isoton III Diluent 20L | GIF | Diluent, Blood Cell | 1 | COULTER Isoton III Diluent |
17 | 15099590663803 | 8448177 | 8448177 | COULTER Lyse S III diff Lytic Reagent (5L) | GGK | Products, Red-Cell Lysing Products | 1 | COULTER Lyse S III diff Lytic Reagent |
18 | 15099590663797 | 8448155 | 8448155 | COULTER Lyse S III diff Lytic Reagent (1L) | GGK | Products, Red-Cell Lysing Products | 1 | COULTER Lyse S III diff Lytic Reagent |
19 | 15099590638191 | 378600 | 378600 | COULTER PrepPlus 2 | PER | Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cyto Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis | 1 | PrepPlus 2 |
20 | 15099590625856 | 8546733 | 8546733 | COULTER Isoton III Diluent (20L) | GIF | Diluent, Blood Cell | 1 | COULTER Isoton III Diluent |
21 | 15099590625771 | 8547148 | 8547148 | COULTER Isoton 4 Diluent (20L) | GIF | Diluent, Blood Cell | 1 | COULTER Isoton 4 Diluent |
22 | 15099590624903 | A31590 | A31590 | The Access Toxo IgG QC is intended for monitoring system performance of the Acce The Access Toxo IgG QC is intended for monitoring system performance of the Access Toxo IgG assay. | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | Access Toxo IgG QC |
23 | 15099590624811 | 33209 | 33209 | The Access CEA QC (BSA matrix) controls are intended for monitoring the system p The Access CEA QC (BSA matrix) controls are intended for monitoring the system performance of immunoenzymatic procedures for the quantitative measurement of Carcinoembryonic Antigen (CEA) using Access CEA reagents. | DHX | System, Test, Carcinoembryonic Antigen | 2 | Access CEA QC |
24 | 15099590583996 | Power Link | B05033 | Power Link | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | Power Link |
25 | 15099590572839 | UPS (CXP) | 626553 | Cytomics FC 500 with CXP Software | GKZ | Counter, Differential Cell | 2 | Cytomics FC500 |
26 | 15099590572822 | UPS (MPL) | 626554 | Cytomics FC 500 MPL with MXP Software | GKZ | Counter, Differential Cell | 2 | Cytomics FC500 |
27 | 15099590542863 | 6602940 | 6602940 | COULTER CLONE MsIgM-FITC | GKZ | Counter, Differential Cell | 2 | CC MsIgM-RD1 |
28 | 15099590542535 | 6602872 | 6602872 | COULTER CLONE MsIgG1 | GKZ | Counter, Differential Cell | 2 | CC MsIgG1 Isotypic Control |
29 | 15099590542511 | 6602884 | 6602884 | COULTER CLONE MsIgG1-RD1 | GKZ | Counter, Differential Cell | 2 | CC MsIgG1-RD1 |
30 | 15099590542399 | 6603838 | 6603838 | COULTER CLONE KC56 (T-200)-FITC (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | COULTER CLONE KC56 (T-200)-FITC |
31 | 15099590542313 | 8547008 | 8547008 | IsoFlow Sheath Fluid | GIF | Diluent, Blood Cell | 1 | ISOFLOW SHEATH FLUID |
32 | 15099590541590 | 6602507 | 6602507 | COULTER CLONE Mo2-FITC | GKZ | Counter, Differential Cell | 2 | CC Mo2-FITC (CD14-FITC) |
33 | 15099590541378 | 6603822 | 6603822 | CYTO-STAT/COULTER CLONE 3A1-RD1 (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | CYTO-STAT/COULTER CLONE 3A1-RD1 |
34 | 15099590541354 | 6603825 | 6603825 | COULTER CLONE 3A1-FITC (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | COULTER CLONE 3A1-FITC |
35 | 15099590540951 | 6602381 | 6602381 | COULTER CLONE B1-FITC | GKZ | Counter, Differential Cell | 2 | CC B1-FITC (CD20-FITC) |
36 | 15099590540890 | 627808 | 627808 | FlowCARE PLG CD4 Reagent (CD45-FITC/CD4-PE) | GKZ | Counter, Differential Cell | 2 | FlowCARE PLG CD4 Reagent |
37 | 15099590540883 | 6603909 | 6603909 | CYTO-STAT/COULTER CLONE Mo2-RD1/KC56(T-200)-FITC | GKZ | Counter, Differential Cell | 2 | CS/CC Mo2-RD1/KC56(T-200)-FITC |
38 | 15099590540449 | 6607077 | 6607077 | IMMUNO-TROL Cells | JPK | Mixture, Hematology Quality Control | 2 | IMMUNO-TROL Cells |
39 | 15099590539757 | 6604500 | 6604500 | CYTO-STAT/COULTER CLONE Mo2-RD1 | GKZ | Counter, Differential Cell | 2 | CS/CC Mo2-RD1 (CD14-RD1) |
40 | 15099590539719 | 6604621 | 6604621 | CYTO-STAT/COULTER CLONE CD3(IgG1)-RD1 | GKZ | Counter, Differential Cell | 2 | CS/CC CD3(IgG1)-RD1 |
41 | 15099590539207 | 6602705 | 6602705 | COULTER CLONE NKH-1 (Analyte Specific Reagent) | MVU | Reagents, Specific, Analyte | 1 | COULTER CLONE NKH-1 |
42 | 15099590250973 | 8547196 | 8547196 | COULTER LH Series Retic Pak Reagent Kit | GGK | Products, Red-Cell Lysing Products | 1 | COULTER LH Series Retic Pak Reagent Kit |
43 | 15099590234089 | 721542 | 721542 | LH Series Cleaner (5L) | JCB | Detergent | 1 | LH Series Cleaner |
44 | 15099590250935 | 8546859 | 8546859 | IsoFlow Sheath Fluid | GIF | Diluent, Blood Cell | 1 | ISOFLOW SHEATH FLUID |
45 | 15099590250751 | 7547201 | 7547201 | COULTER TruColor Giemsa Stain | KQC | Stains, Hematology | 1 | COULTER TruColor Giemsa Stain |
46 | 15099590250720 | 7547180 | 7547180 | COULTER TruColor Wright Stain Buffer | KQC | Stains, Hematology | 1 | COULTER TruColor Wright Stain Buffer |
47 | 15099590250690 | 7546915 | 7546915 | COULTER LATRON Primer | GKL | Counter, Cell, Automated (Particle Counter) | 2 | COULTER Latron |
48 | 15099590233785 | 628028 | 628028 | COULTER Retic-X Cell Control | JPK | Mixture, Hematology Quality Control | 2 | COULTER Retic-X |
49 | 15099590233686 | 628017 | 628017 | COULTER DxH Diluent | GIF | Diluent, Blood Cell | 1 | COULTER DxH Diluent |
50 | 15099590232931 | 177017 | 177017 | QuickComp 4 Kit | GKZ | Counter, Differential Cell | 2 | QuickCOMP 4 Kit |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | M58802000780030 | DMS-100 | 020-007800-3 | The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab | Cinema MAS & MMS | STEREOTAXIS, INC. |
2 | M58800100790010 | Link | 001-007900-1 | The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab | Odyssey | STEREOTAXIS, INC. |
3 | M58800100784010 | Studio | 001-007840-1 | The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab | Odyssey Cinema | STEREOTAXIS, INC. |
4 | M58800100781010 | EIF | 001-007810-1 | The Odyssey Workstation is an optional display and user interface package design The Odyssey Workstation is an optional display and user interface package designed to consolidate the point of control in the Catheter Lab | Odyssey Enterprise Interface | STEREOTAXIS, INC. |
5 | 09420012424266 | 900ICON203 | 900ICON203 | F&P InfoUSB | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED |
6 | 09352527001192 | VFPROEX24.03 | ProEX Telehealth Hub System FSC2 - NTSC - CLIN - v3 | Visionflex | VISIONFLEX PTY. LTD. | |
7 | 09352527001185 | VFPROEX23.03 | ProEX Telehealth Hub System GEIS - CLIN - v3 | Visionflex | VISIONFLEX PTY. LTD. | |
8 | 09352527001161 | VFPROEX21.03 | ProEX Telehealth Hub System Standard - CLIN - v3 | Visionflex | VISIONFLEX PTY. LTD. | |
9 | 09352527000669 | VFPROEXMOBILE1.01 | ProEX Mobile Telehealth Hub | Visionflex | VISIONFLEX PTY. LTD. | |
10 | 09352527000614 | VFPROEX21.03 | ProEX Telehealth Hub System Standard - CLINICIAN v3 | Visionflex | VISIONFLEX PTY. LTD. | |
11 | 09352527000607 | VFPROEX26.02 | ProEX Telehealth Hub System FSC3 CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
12 | 09352527000591 | VFPROEX25.02 | ProEX Telehealth Hub System FSC2 CUSTOMER SUPPLIED - CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
13 | 09352527000584 | VFPROEX24.02 | ProEX Telehealth Hub System FSC2 - NTSC - CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
14 | 09352527000577 | VFPROEX23.02 | ProEX Telehealth Hub System GEIS - CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
15 | 09352527000560 | VFPROEX22.02 | ProEX Telehealth Hub System FSC2 PAL - CLINICIAN v2 | Visionflex | VISIONFLEX PTY. LTD. | |
16 | 09352527000553 | VFPROEX21.02 | The ProEX Imaging Hub is specifically designed and engineered to enable health p The ProEX Imaging Hub is specifically designed and engineered to enable health practitioners all over the world to confidently carry out detailed medical examinations on patients based in regional, remote, rural and urban areas. | Visionflex | VISIONFLEX PTY. LTD. | |
17 | 09350855000214 | N05007 | RFID Medical Instrument tag | trophon AcuTrace Medical Instrument Tag | NANOSONICS LIMITED | |
18 | 09350855000207 | N05006 | RFID Operator card | trophon AcuTrace Operator Card | NANOSONICS LIMITED | |
19 | 08714729975700 | M00420020620 | M00420020620 | LABSYSTEM™ PRO EP Review Workstation Software | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION |
20 | 08714729884002 | M00420020300 | LABSYSTEM™ PRO EP Review Workstation Software, V2.7 | LABSYSTEM™ PRO | BOSTON SCIENTIFIC CORPORATION | |
21 | 08437014572308 | 1006 | KIRO Link is a software intended to store, convert formats, transfer and display KIRO Link is a software intended to store, convert formats, transfer and display the medical data required for the integration and workflow management functionalities of compounding associated technologies. These technologies include customer site software (Computerized Physician Order Entry (CPOE), logistics, quality control, etc.), Pharmacy Compounding Devices (PCDs) and compounding assisting software. The software is intended to be used only by qualified pharmacy personnel. | KIRO Link | KIRO GRIFOLS SL. | |
22 | 08052286590173 | EI KT0 0005 521 | Echolaser Smart Interface (ESI) and its accessories | Echolaser Smart Interface (ESI) | ELESTA SPA | |
23 | 08033737713037 | THD Procto Software | 760004 | The THD Procto Software System is a diagnostic system intended to be used to inv The THD Procto Software System is a diagnostic system intended to be used to investigatepelvic floor disorders, and specifically the THD Procto Software together with its accessories and devices (endoanal probe, video camera and THD Anopress), is able to be applied for:- Endoanal ultrasound (trans-rectal ultrasound / echography)- Anoscopy exams- Manometry exams | THD Procto Software System | THD SPA |
24 | 07613327505245 | 0101-2200 | 0101-2200 | Digital Port Connector | ADAPT | STRYKER LEIBINGER GMBH & CO. KG |
25 | 07613327482690 | 9222110000 | 9222-110-000 | System 9 Non-Sterile Battery, Small | N/A | STRYKER CORPORATION |
26 | 07613327482652 | 9126110000 | 9126-110-000 | System 9 Non-Sterile Battery, Large | N/A | STRYKER CORPORATION |
27 | 07613327467888 | 4608000000 | 4608-000-000 | System 9 Sagittal Saw | Sabo | STRYKER CORPORATION |
28 | 07613327467871 | 4605000000 | 4605-000-000 | System 9 Cordless Driver Handpiece | NA | STRYKER CORPORATION |
29 | 07613327467864 | 9209000000 | 9209-000-000 | System 9 Stryker Saw | Precision | STRYKER CORPORATION |
30 | 07613327467857 | 9208000000 | 9208-000-000 | System 9 Sagittal Saw | NA | STRYKER CORPORATION |
31 | 07613327467840 | 9207000000 | 9207-000-000 | System 9 Sternum Saw | NA | STRYKER CORPORATION |
32 | 07613327467833 | 9203000000 | 9203-000-000 | System 9 Single Trigger Rotary Handpiece | NA | STRYKER CORPORATION |
33 | 07613327467826 | 9206000000 | 9206-000-000 | System 9 Reciprocating Saw | NA | STRYKER CORPORATION |
34 | 07613327467819 | 9205000000 | 9205-000-000 | System 9 Dual Trigger Rotary Handpiece | NA | STRYKER CORPORATION |
35 | 07613327467765 | 9202000000 | 9202-000-000 | System 9 Saw | EZout | STRYKER CORPORATION |
36 | J00714000630631 | 1400063 | 1400063 | iOptima consoles are control units designed to drive Bien-Air Dental SA's dental iOptima consoles are control units designed to drive Bien-Air Dental SA's dental micromotors, and to control torque, speed, and direction of rotation via an Apple iDevice (iPod or iPad). | iOptima APP | BIEN-AIR DENTAL SA |
37 | J00714000520521 | 1400052 | 1400052 | iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromo iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad). | iChiropro Surgery APP | BIEN-AIR DENTAL SA |
38 | J00714000510511 | 1400051 | 1400051 | iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromo iChiropro console a driver designed to drive Bien-Air Dental SA's dental micromotors, via an Apple iDevice (iPod or iPad). | iChiropro APP | BIEN-AIR DENTAL SA |
39 | 07540196002394 | 01-111730 | 01-111730 | Data logger for Bravo Chamber Autoclave | Data Logger Bravo (T) | SCICAN LTD |
40 | 07540196002387 | 01-111729 | 01-111729 | Data logger for Bravo Chamber Autoclave | Data Logger Bravo (G) | SCICAN LTD |
41 | 07540196000963 | 01-111770 | 01-111770 | Data logger for Statim Cassette Autoclaves and Hydrim Instrument Washers | Data Logger Statim/Hydrim | SCICAN LTD |
42 | 07392532242380 | 75751 | 75751 | Navina Smart Transanal Irrigation. Bowel diary APP | Navina™ Smart App for Android | DENTSPLY IH AB |
43 | 07392532242373 | 75750 | 75750 | Navina Smart Transanal Irrigation. Bowel diary APP | Navina™ Smart App for iOS | DENTSPLY IH AB |
44 | 07350111070014 | 12000 | CoroFlow | COROVENTIS RESEARCH AB | ||
45 | 07350040976036 | CSS-0000NG | CSS-0000NG | The CellaVision Server Software is a network optimization design to create workf The CellaVision Server Software is a network optimization design to create workflow efficency in lager organizations and enables easy data transfer from all connected analyzers to a centralized database residing on a single server. | CellaVision® Server Softwaren, Upgrade to next generation | CELLAVISION AB |
46 | 07350040975961 | CSS-000099 | CSS-000099 | The CellaVision Server Software is a network optimization design to create workf The CellaVision Server Software is a network optimization design to create workflow efficency in lager organizations and enables easy data transfer from all connected analyzers to a centralized database residing on a single server. | CellaVision® Server Softwaren Non-expiring license | CELLAVISION AB |
47 | 07332747197136 | 3.13 | 300547 | DTX Studio Core 3.13 for Windows 64-bit | DTX Studio™ Core | NOBEL BIOCARE AB |
48 | 07332747187090 | 3.11 | 300547 | DTX Studio Core 3.11 for Windows 64-bit | DTX Studio™ Core | NOBEL BIOCARE AB |
49 | 07332747185102 | 3.10 | 300547 | DTX Studio Core 3.10 for Windows 64-bit | DTX Studio™ Core | NOBEL BIOCARE AB |
50 | 07332747180817 | 3.9 | 300547 | DTX Studio Core 3.9 for Windows 64-bit | DTX Studio™ Core | NOBEL BIOCARE AB |